Data Foundry

Medical device recalls 2018

JS Series SterilContainer S2 System — Class II medical device recall Z-0624-2018

Terminated recall by Aesculap Implant Systems LLC, reported 2018-02-21. The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clear

Recall numberZ-0624-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAesculap Implant Systems LLC, Center Valley, PA, United States
Recall initiated2017-09-08
Classified2018-02-15
Reported by FDA2018-02-21
Terminated2019-04-04
Quantity292 units

Product

JS Series SterilContainer S2 System

Reason for recall

The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0624-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.